Chronic Kidney DiseaseNCT02808572
New Biomarkers of Bone Mineral Metabolism as Cardiovascular Risk Factors in Chronic Kidney Disease Patients
A study testing Plasma osteoprotegerin level, Plasma fibroblast growth factor 23 level and Vascular calcification score in people with Chronic Kidney Disease, run by University Hospital, Montpellier at 7 sites in France.
Trial summary
To evaluate the relationships between bone mineral metabolism markers (osteoprotegerin, fibroblast growth factor 23) at inclusion and the occurence of cardiovascular events during a 7 year follow-up. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Plasma osteoprotegerin level, Plasma fibroblast growth factor 23 level and Vascular calcification score
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 7 sitesFrance
- Study dates
- 12 Mar 2013to Jun 2031
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient who has signed the written consent form
- Patient with chronic renal failure defined by glomerular filtration rate (GFR) but without dialysis therapy
Who cannot join
- Pregnancy
- Patient with chronic renal failure requiring dialysis therapy
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
France7 sites, 4 recruiting
- Recruiting
AIDER
Montpellier
Lotfi Chalabi, Dr
Lotfi Chalabi, Dr
- Active, not recruiting
CHU Montpellier, Cardiology department
Montpellier
- Recruiting
CHU Montpellier, Endocrinology department
Montpellier
Eric Renard, Prof
Eric Renard, Prof
- Active, not recruiting
CHU Montpellier, Intensive care unit
Montpellier
- Active, not recruiting
CHU Montpellier, Internal medicine department
Montpellier
- Recruiting
CHU Montpellier, Nephrology department
Montpellier
Hélène Leray-Moragues, Dr
Hélène Leray-Moragues, Dr
- Not yet recruiting
AIDER
Saint-Jean-de-Védas
Marie BONNET, m.bonnet@aidersante.com
About this study
Official title: New Biomarkers of Bone and Mineral Metabolism as Risk Factors for Morbidity/Mortality in Chronic Kidney Disease Patients Not Requiring Dialysis
To evaluate the relationships between bone mineral metabolism markers (osteoprotegerin, fibroblast growth factor 23) at inclusion and the occurence of cardiovascular events during a 7 year follow-up.
- Conditions
- Chronic Kidney Disease
- Being tested
- Plasma osteoprotegerin level, Plasma fibroblast growth factor 23 level, Vascular calcification score
- Keywords
- chronic kidney disease, vascular calcifications, cardiovascular risk
- Medical subject headings
- Renal Insufficiency, Chronic, Vascular Calcification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma osteoprotegerin levelBiological
dosage of plasma osteoprotegerin
Plasma fibroblast growth factor 23 levelBiological
dosage of plasma fibroblast growth factor 23
Vascular calcification scoreProcedure or surgery
measurement of vascular calcification score by multidetection computerized tomography
| Study group | Role | What they receive |
|---|---|---|
| Cardiovascular risk evaluation | Experimental | Measurement at inclusion of plasma osteoprotegerin level, plasma fibroblast growth factor 23 level, vascular calcification score and record of cardiovascular events during the 3 year follow-up Receives: Biological: Plasma osteoprotegerin level; Biological: Plasma fibroblast growth factor 23 level; Procedure: Vascular calcification score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of at least one cardiovascular event during the 7 year follow-up according to osteoprotegerin level at inclusion
osteoprotegerin will be measured in picomol/L
Measured: 7 years after inclusion
Secondary outcomes (4)
Occurence of at least one cardiovascular event during the 7 year follow-up according to fibroblast growth factor 23 level at inclusion
fibroblast growth factor 23 will be measured in RU/milliliter
Measured: 7 years after inclusion
Occurence of at least one cardiovascular event during the 7 year follow-up according to vascular calcification score at inclusion
Measured: 7 years after inclusion
Mortality
Measured: 7 years after inclusion
Kidney functions
values of creatinine
Measured: during the 7 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study start12 Mar 2013
- Primary completionMar 2024 (estimated)
- Study completionJun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Paul CRISTOL, Prof, Principal investigator, CHU Lapeyronie, Department of Biochemistry and Hormonology, Montpellier, FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02808572
- Sponsor's protocol ID
- UF9125
- Status last verified
- Dec 2021
- First submitted
- 17 Jun 2016
- Last updated
- 4 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No